Marketing Authorisation of Medicinal Products in Spain – AEMPS Procedures

Overview of Marketing Authorisation Pathways

In Spain, medicinal products require prior marketing authorisation from AEMPS or the European Medicines Agency (EMA) before they can be commercially distributed. The authorisation process ensures compliance with EU standards for quality, safety, efficacy, and benefit-risk balance. There are four main routes: national (purely Spanish), decentralised (multiple Member States with one Reference Member State), mutual recognition (based on an existing authorisation in another Member State), and centralised (EU-wide via EMA for certain categories such as biotechnology products, orphan medicines, and those with new active substances). Comercialización de medicamentos - AEMPS

National Authorisation Procedure

• Scope: Applies to medicines intended only for the Spanish market or those not falling under mandatory centralised procedure.
• Application: Submitted to AEMPS with full dossier including quality, non-clinical, and clinical data (Module 1–5 of CTD format).
• Assessment: AEMPS evaluates the application within 210 days (standard timeline), with possible clock-stops for questions to the applicant.
• Outcome: If positive, AEMPS issues a national marketing authorisation; negative decisions can be appealed.

Decentralised and Mutual Recognition Procedures

• Decentralised Procedure (DCP): Used for new products seeking authorisation in multiple Member States simultaneously; one Reference Member State (RMS) leads assessment, with Concerned Member States (CMS) providing input.
• Mutual Recognition Procedure (MRP): Applied when a product is already authorised in one Member State and the holder seeks recognition in others; RMS leads, CMS recognise the authorisation.
• Role of AEMPS: Can act as RMS or CMS; participates in coordination groups and provides scientific input.

Centralised Procedure

• Mandatory Scope: Applies to biotechnology products, orphan medicines, advanced therapy medicines, certain new active substances, and others listed in Regulation (EC) No 726/2004.
• Process: Single application to EMA; Committee for Medicinal Products for Human Use (CHMP) issues opinion; European Commission grants EU-wide authorisation.
• AEMPS Involvement: Participates as rapporteur/co-rapporteur or provides input during CHMP assessment.

Post-Authorisation Obligations

• Variations: Changes to authorised products (minor, major) require prior approval or notification via AEMPS or EMA depending on procedure.
• Renewal: Authorisations renewed after 5 years (national) or per centralised rules.
• Pharmacovigilance: Continuous monitoring and reporting of adverse reactions; risk management plans implemented.
• Periodic Safety Update Reports: Submitted at defined intervals.

Practical Information

AEMPS publishes detailed guidance on application requirements, fees, timelines, and electronic submission via the CIMA portal. Applicants must comply with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP). The agency also maintains the public CIMA database listing all authorised medicines in Spain.

This authorisation framework integrates Spain into the EU medicines market while ensuring rigorous national oversight for products relevant to Spanish public health. Complete procedural details, application forms, guidance documents, and the CIMA database are accessible on the AEMPS commercialisation section. Comercialización de medicamentos - AEMPS